S9600 Non-invasive Ventilator Operation Manual Nanjing Superstar Medical Equipment Co., Ltd. Contents 1Safety item................................................................................................................................... 1 2Remarks of the picture, sign, term and abbreviation in the machine and manual........... 3 3 Statement....................................................................................................................................5 4 Operation scope.........................................................................................................................6 4.1 Intended use.................................................................................................................... 6 4.2 Contraindication...............................................................................................................6 4.3 Precautions...................................................................................................................... 6 5 EMC Information........................................................................................................................7 6 Main structure and operating principle.................................................................................12 6.1 Structure......................................................................................................................... 12 6.2 Operating principle........................................................................................................13 7Preparation................................................................................................................................ 14 7.1Installation of wetting cup..............................................................................................14 7.2Fill water in the wetting cup.......................................................................................... 14 7.3Installation of filtering cotton.........................................................................................15 7.4 Installation of SD card.................................................................................................. 15 7.5Connection of power supply......................................................................................... 16 7.6Connection of breathing tube and mask.....................................................................16 7.7Machine operating environment.................................................................................. 17 8 Check before operation.......................................................................................................... 18 8.1Check interval................................................................................................................. 18 8.2System check..................................................................................................................18 8.3Check of ventilation function........................................................................................ 18 9 Operation.................................................................................................................................. 19 9.1 Operation keys.............................................................................................................. 19 9.2Power-on......................................................................................................................... 19 9.3Ventilation mode selected.............................................................................................20 9.4 Parameters setting in ventilation mode..................................................................... 22 9.5 Alarm setting.................................................................................................................. 25 9.6 System setting............................................................................................................... 26 9.7 Operation of humidifier.................................................................................................27 9.8 Start-up/standby............................................................................................................ 27 9.9 Audio paused of alarm..................................................................................................27 9.10 Ventilation operation...................................................................................................28 9.11 On completion..............................................................................................................28 I 10 Alarm, warning and hint information...................................................................................29 11 Cleaning and maintenance.................................................................................................. 30 11.1 Clearance and disinfection of the contact part with patient..................................30 11.2 Cleaning of S9600...................................................................................................... 30 11.3 Cleaning of wetting cup..............................................................................................31 11.4 Cleaning of filtering sponge.......................................................................................31 12 Maintenance...........................................................................................................................32 12.1 Before everyday operation........................................................................................ 32 12.2 After operation of every patient.................................................................................32 12.3 Assemble after disinfection........................................................................................32 12.4 Every day or in case of needed................................................................................32 12.5 Every month or over 300 hours................................................................................ 32 12.6 Every year or operation over 4000 hours............................................................... 33 13 Disposal of wastes................................................................................................................ 34 13.1 Disposal of electronic and plastic parts...................................................................34 13.2 Scrap disposal of medical equipment......................................................................34 14 Alarm and handling............................................................................................................... 35 15 Troubleshooting..................................................................................................................... 38 16 Main technical specification.................................................................................................39 16.1 Environment conditions..............................................................................................39 16.2 Classification................................................................................................................39 16.3 Power supply............................................................................................................... 39 16.4 Electromagnetic Compatibility.................................................................................. 39 16.5 Ventilation mode..........................................................................................................40 16.6 Ventilation parameter adjustment.............................................................................40 16.7 Ventilation parameter Monitoring range.................................................................. 42 16.8 Alarm, hint and protection..........................................................................................44 16.9 Noise.............................................................................................................................44 17 Move, storage and transportation.......................................................................................45 17.1 Move............................................................................................................................. 45 17.2 Storage......................................................................................................................... 45 17.3 Transportation..............................................................................................................45 18 After-sales service commitments........................................................................................46 II 1Safety item ! △ Note: This machine is applied to adult patients only, not for life support. Non-invasive Ventilator is subject to the possibility of repetitive breathing. To reduce this possibility, pay attention to the following: Only breathing tubes and facemasks provided by our company or recommended by a physician shall be used. Don’t block the expiratory port. When this machine is not turned on, avoid wearing the face mask and headband for a long time. In case of any of the following, do not use this machine anymore and contact our company: Excessive temperature of air output from this machine or peculiar smell of this air; This machine generates abnormal or shrill noise; This machine falls from high place, water enters this machine, or machine casing is damaged. To prevent electric shock, please disconnect the power supply before cleaning this machine; never dip this machine in any liquid. ! △ Warning: This manual serves as a reference. The instructions in this manual are not intended to supersede the instructions of your care giver. You should read and understand this entire manual before using this machine. This Non-invasive Ventilator shall be used by physician or under physician’s guidance. Do not use this machine before doctor helps you to select required treatment pressure and parameters. Never tilt or put this machine complete with the humidifier upside-down, to prevent back flow of liquid inside the humidifier into this machine. In case user needs to carry this machine, first empty water in the humidifier; never carry it with water inside. Do not use the machine in ambient temperatures above 35℃. If the machine is used at ambient temperatures above 35℃, the temperature of the breathing air may exceed 41℃, which could cause thermal irritation or injury to your airway. Never use this machine if the air contains inflammable, explosive, or anesthetic gas. Do not operate the machine in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the machine. Do not disassemble the machine without the authorization from our company. If the user needs to repair, this machine can only be operated by special qualified personnel after training. Never use the antistatic threaded pipe and facemask. It may be cause inflammation if use this 1 kind of threaded pipe and face mask near the high frequency electric operation equipments. Use of mobile phone or other RF radiating equipment near this machine may cause unexpected problem or abnormity. In case RF radiating source exists nearby, machine operating status shall be monitored. Use of other electrical equipment on or near this system may cause interference. Before this machine is used for a patient, check if this machine is operating normally according to your configuration. Same or similar equipment used in any separate area that adopts different alarm settings may cause potential hazard. Use of medical equipment with similar or seemingly same appearance but different software and internal functions (including default operations upon alarm and other alarm characteristics) may cause disorder among operators. This machine is subject to the possibility of re-inhalation of exhaled carbon dioxide. Under normal status or single fault status, face mask (or connector) with air vent or exhaust machine shall be used matching this machine, to reduce re-inhalation of exhaled carbon dioxide to a minimum. Under normal operating status of this machine, maximum pressure is limited to 35cmH2O. Under single fault condition, maximum pressure is limited to 40cmH2O. In case environment/power supply (power supply and gas supply) exceeds the following limit, if one parameter is changed but other parameters are in normal range, operation of this machine can continue. Parameter may exceed its limit but shall not cause safety hazard to patient or operator. Ambient temperature:5℃-40℃; Relative humidity :10%-95%; Atmospheric pressure :700mbar-1060mbar; AC power supply voltage:-15% - +10% of rated voltage DC power supply voltage:-15% - +25% of rated voltage In case of interruption of power supply during normal operation, machine operation will stop. After the power supply is restored, the operation manual can be followed to store normal machine operation. Under normal operating status, maximum flow of this breathing machine under operating pressure of 8cmH2O, 16cmH2O, or 25cmH2O is 50L/min, 100L/min, or 145L/min respectively. 2 2Remarks of the picture, sign, term and abbreviation in the machine and manual “ ” indicates ‘Follow instructions for use’. “ warning ” and “ note” indicate if the instruction is not followed, there will be some emergencies, please read and keep to all the “ warning” and “note” items. Warning: indicates that if the instruction is not followed, the machine may be damaged, you and your patient may be injured. Note: indicates that if the instruction is not followed , the machine may be damaged, and can not work normally. Hint:indicate you should pay attention to the explanation. In the machine and manual, the picture, sign, term and abbreviation are used to replace the language remarks. However, all these picture, sign, term and abbreviation are not all involved in the machine and manual. Table 1 Remarks of the picture, sign, term and abbreviation in the machine and manual Picture, sign, term and abbreviation Explanation Follow instructions for use Type BF applied part Class Ⅱ Alarm audio paused Alarm audio closed Heat level of humidifier · System settings start/paused The device, accessories and the packaging have to be disposed of waste correctly at the end of the usage. Please follow Local Ordinances or Regulations for disposal. cmH2O Centimeters of water 3 Picture, sign, term and abbreviation Explanation bpm Breath per minute mL Milliliter s Second (Unit for time) L/min Liter per minute CPAP Continuous Positive Airway Pressure IPAP Inspiratory Positive Airway Pressure EPAP Expiratory Positive Airway Pressure AUTO Automatic pressure titration function. AVAPS Average volume assures pressure support S/T Spontaneous/Time control ventilation Para Set Parameter Setting Tramp Ramp Time VT Tidal Volume Para Set Parameter Setting Tramp Ramp Time Freq Frequency Tinsp Inspiratory Time Trise Rise Time Vitr Inspiratory Trigger Vetr Expiratory Trigger Pup Pressure upper limit 4 Picture, sign, term and abbreviation Explanation MVlow Minute Volume low limit Fup Frequency upper limit FLow Frequency low limit Discon Disconnect Pup!! Ppeak High alarm MV Low!! Minute Volume Low alarm Fup!! Frequency High alarm FLow!! Frequency low alarm 3 Statement S9600 Non-invasive Ventilator features the following monitoring, alarm, and protection devices: —Breathing pressure measuring and control device —Frequency measuring and control device —Inspiratory time measuring and control device —VT and MV measuring —Pressure upper limit alarm and limiting device —MV low limit alarm —Frequency upper and low limit alarm —Disconnect alarm —Apnea alarm 5 4 Operation scope 4.1 Intended use S9600 is intended to provide non-invasive ventilation in adult patients for the treatment of obstructive sleep apnea and not for life support. This machine may be used in the hospital or home. 4.2 Contraindication Use of this product is prohibited in case of the following: Obstruction of upper respiratory tract High risk of erroneous inhalation, incapability of removal of secretion from oral pharynx and respiratory tract, or poor protection of respiratory tract Trauma, burn, or anomaly of cervical part or face Pneumothorax not drained1 Recent operation in face, cervical part, oral cavity, pharynx cavity, esophagus, or stomach1 Obvious noncooperation or extreme stillness1 Excessive air passage secretion or obstruction in phlegm discharge1 Note: 1 indicates relative contraindication. For such patients, advantages and disadvantages of trauma-free positive pressure ventilation shall be very carefully balanced, to decide use of trauma-free positive pressure ventilation (1mmHg=0.133kPa) or not. 4.3 Precautions Immediately report any unusual chest discomfort, shortness of breath, or severe headache to your physician or dealer. If skin irritation or breakdown develops from the mask, refer to the mask instructions for appropriate action. The following are potential side effects of noninvasive positive pressure therapy: • ear discomfort • conjunctivitis • skin abrasions due to noninvasive interfaces • gastric distention (aerophagia) 6 5 EMC Information Important Notice The S9600 Non-invasive Ventilator meets the requirement of electromagnetic compatibility in IEC60601-1-2. The user needs to install and use according to electromagnetism compatibility information which is attached with it. Portable and mobile RF communication devices may influence S9600 performance, so S9600 should be kept away from them during using. Guidance and manufacturer’s declaration stated in the appendix. Warning: S9600 Non-invasive Ventilator should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, S9600 should be observed to verify normal operation in the configuration in which it will be used. Class A equipment is intended for use in an industrial environment. S9600 may be potential difficulties in ensuring electromagnetic compatibility in other environments, due to conducted as well as radiated disturbances. 7 Table 1 Guidance and manufacturer’s declaration –electromagnetic emissions The S9600 Non-invasive Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the SECP-II should assure that it is used in such an environment. Emissions test RF emissions CISPR 11 Compliance Electromagnetic environment - guidance Group 1 The S9600 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations / flicker emissions IEC 61000-3-3 Complies The S9600 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 8 Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity The S9600 Non-invasive Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the S9600 should assure that it is used in such an environment. Immunity test IEC 60601 test level Electrostatic discharge (ESD) ±6 kV contact ±8 kV air Compliance level Electromagnetic environment – guidance ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. Surge ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth Mains power quality should be that of a typical commercial or hospital environment. <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s Mains power quality should be that of a typical commercial or hospital environment. If the user of the S9600 requires continued operation during power mains interruptions, it is recommended that the S9600 be powered from an uninterruptible power supply or a battery. IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) 3 A/m 3 A/m magnetic field IEC 61000-4-8 NOTE Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. UT is the a.c. mains voltage prior to application of the test level. 9 Table 3 Guidance and manufacture’s declaration – electromagnetic immunity The S9600 Non-invasive Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of S9600 should assure that it is used in such an environment. IEC 60601 test Complianc Immunity test Electromagnetic environment - guidance level e level Portable and mobile RF communications equipment should be used no closer to any part of the S9600,, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF 3 Vrms 3V d 1.2 P IEC 61000-4-6 150 kHz to 80 MHz 3 V/m Radiated RF IEC 61000-4-3 3 V/m d 1.2 P 80 MHz to 800 MHz d 2.3 P 800 MHz to 2.5 GHz 80 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a b Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the S9600 is used exceeds the applicable RF compliance level above, the S9600 Non-invasive Ventilator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the S9600. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 10 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the S9600 Non-invasive Ventilator The S9600 Non-invasive Ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the S9600 Non-invasive Ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the S9600 Non-invasive Ventilator as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz ~ 80 MHz d = 1 .2 P 80 MHz ~ 800 MHz d =1,2 800 MHz~ 2,5 GHz d = 2,3 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7,3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 11 6 Main structure and operating principle Non-invasive Ventilator is comprised of main machine, humidifier, breathing tube and facemask. 6.1 Structure 1 Key (used to modify machine working parameters and control machine operating status) 2 Display screen (display system settings, monitoring parameters, wave form, alarm, etc) 3 Inspiratory port (connected to 1.8m breathing tube); display of humidifier grade 4 Wetting cup 5 DC power supply interface (connected to 24V DC power supply cable) 6 Filtering cotton and air inlet 7 label 8 Water box cover Fig.1 Whole machine outline Note: The male 22mm conical connector complied with ISO 5356-1 should be used in inspiratory port (patient port). 12 6.2 Operating principle See Fig.2 for operating principle block diagram. Fig.2 Operating principle block diagram The fan adjusts air to required pressure and delivers it to patient via the humidifier. The control board carries out processing according to parameters set on the panel and air passage pressure and flow data acquired by sensors, and displays control values and monitored values on the panel. The control board also generates audio and video alarm when a monitored breathing parameter exceeds the alarm setting according to alarm parameters set on the panel. 13 7Preparation 7.1Installation of wetting cup Align wetting cup mounting groove to corresponding fixing groove on main part of this machine. Lightly push the cup to the bottom and sway left and right to check for looseness and ensure proper connection, as shown in the figure below: 7.2Fill water in the wetting cup As shown in 7.1, take out the wetting cup in the reserve direction; Use a water sup to add suitable amount of pure water or running water into the wetting cup; as shown below: ! △ Notice 1) When the water box is placed horizontally, its filled volume shall be not more than 300mL and its water level shall be parallel with the maximum scale. If filled volume is too large and the device is placed at a slant angle, water will enter user’s trachea or body which will injure the patients and damage the device. 2) When water volume is less than the minimum scale, please add pure water or tap water appropriately to avoid damaging the device. 14 7.3Installation of filtering cotton As shown in Fig.1, pull up the gas inlet (6) by hand. Lightly pinch two sides of clean filtering cotton to place it inside the air inlet. Pay attention to allow good contact between filtering cotton and air inlet. To prevent blocking of air inlet, the filtering cotton must not be deformed. 7.4 Installation of SD card Open the silicone cover marked Micro-SD and insert SD card into the hole, then put silicone cover back, as shown in follow figure: Note: 1)When installing SD card, its metal surface shall be put upward, as shown in right figure; 2)Open the silicone cover from one end of word SD, because another end is connected with the machine. 15 7.5Connection of power supply Insert AC plug of the power supply adapter into the AC socket and insert the DC plug of the DC power supply adapter into the DC power interface at a side of the main part of the machine. Refer to the figure below: 7.6Connection of breathing tube and mask ! △ Note: 1)The breathing tube should meet the requirement of Standard of ISO 5367; 2)The mask should meet the requirement of Standard of ISO 17510-2; 3)Refer to operation manual for mask’s operation. As shown in below Fig: 1 Non-invasive Ventilator 2 breathing tube 3 mask Note: During operation of the machine, do not block the air leakage hole. If total face mask is used, such mask must have safety valve, to prevent suffocation of patient in case of interruption of power supply. 16 7.7Machine operating environment S9600 Non-invasive Ventilator shall be placed on a solid and stable desktop, away from heating and cooling equipment (air conditioning and electric blanket etc.), to prevent blocking of machine air inlet by cotton wool, quilt, blanket, or other object. To ensure normal operation of the machine, free air flow shall be maintained around the machine. 17 8 Check before operation ! △ Warning: 1) In order to ensure the excellent performance in operation, connection, safety feature and alarm function must be checked before operation. 2) Do not use machine with problem. If there is alarm from the machine, do not use it, for machine may be damaged, or the patient may be injured. 8.1Check interval Please make check before operation under the following situation: Before usage of every patient; After maintenance and disinfection; After repairing. 8.2System check Check all connection part is stable and correct; Check the breathing circuit pipe is in good condition and are connected stable and correct; The connection of the power lines are stable. 8.3Check of ventilation function Block the connection point between the breathing tube and the mask. Switch on the machine. After the machine is switched on, in default mode, this machine shall supply air according to default parameters and no abnormity shall be displayed. 18 9 Operation 9.1 Operation keys 1 Standby/start key 2 System setting key 3 Adjusting shuttle Fig 3 Panel operation keys 9.2Power-on Connect the power supply. Enter starting up interface (First starting up and default S/T Mode), see Fig. 3, rotate adjusting shuttle (item 3 in Fig. 3) to enter the second interface, see Fig.4. When AVAPS is off, the display screen will not display maximum and minimum value of IPAP, the second interface will not display the setting value of VT, see Fig.5. Fig 4 First starting up interface 19 Fig 5 AVAPS is off—starting up interface Note: The next starting up interface works for the last run. 9.3Ventilation mode selected First press keys “ ” and “ ” (item1 and 2 in Fig.3) at the same time. Then insert power supply. The default interface will be displayed, as shown in Fig.4, or the last operation interface. Press key “ ” (item 2 in Fig.3), parameter set interface will be displayed; Rotate the shuttle knob (item 3 in Fig.3) to select the needed mode. Press the shuttle knob (3 in Fig.3) so that the selected mode is displayed in reverse color. See Fig.11, Fig.12, Fig.13, Fig.14 and Fig.15. Rotate the shuttle knob (3 in Fig.3) to “OK”, press it to exit. The machine will operate under the selected mode. See Fig.6, Fig.7, Fig.8, Fig.9 and Fig.10 for other ventilation modes (Fig.6, Fig.7 , Fig.8, Fig.9 and Fig.10 before closing AVAPS and after closing AVAPS). Fig. 6 Interface of S/T Mode 20 Fig. 7 Interface of S Mode Fig. 8 Interface of PC Mode Fig. 9 Interface of T Mode Fig.10 Interface of CPAP Mode 21 9.4 Parameters setting in ventilation mode Press the key “ ” (item 2 in Fig.3), parameter setting interface will be displayed, as shown in Fig. 11, Fig. 12, Fig. 13, Fig. 14 and Fig. 15. Rotate the shuttle knob (item 3 in Fig.3) to select the needed setting option. Press the shuttle knob (item 3 in Fig.3) so that the selected setting option is displayed in reverse color. Rotate the “Shuttle adjustment/confirm” knob (3 in Fig.3) to achieve required value of the parameter: clockwise to increase the parameter value and counterclockwise to decrease the parameter value. Press the shuttle knob (item 3 in Fig.3) to confirm setting of this parameter. To adjust the next parameter, repeat steps described earlier. Rotate the shuttle knob (item 3 in Fig.3) to “OK”. Confirm settings and exit. The machine will run according to adjusted ventilation parameters. Fig.11 Parameter setting interface in S/T mode When AVAPS is on, the following parameters can be adjusted: IPAPmax, IPAPmin, EPAP, Tramp, Freq, Tinsp, Vitr, Vetr and VT. 22 Fig.12 Parameter setting interface in T mode When AVAPS is on, the following parameters can be adjusted:IPAPmax, IPAPmin, EPAP, Tramp, Freq, Tinsp and VT. Fig.13 Parameter setting interface in S mode When AVAPS is on, the following parameters can be adjusted: IPAPmax, IPAPmin, EPAP, Tramp, Vitr, Vetr , Auto and VT 23 Fig.14 Parameter setting interface in CPAP mode When AVAPS is on, the following parameters can be adjusted: IPAPmax, IPAPmin, EPAP, Tramp, Tinsp, Vetr and VT. Fig.15 Parameter setting interface in CPAP mode Note: During parameter setting, the machine will operate according to ventilation and alarm parameters of the last mode. Hint: 1) Selected item will be displayed in reverse color; same below. 2) When AVAPS is on, IPAP has maximum and minimum value two parameters. 3) When reaching maximum value or minimum value of adjustment range, adjustment of this machine will stop automatically. 24 9.5 Alarm setting Press the key “ ” (item 2 in Fig.3) twice; Alarm setting interface will be displayed; as shown in Fig.16. Rotate the shuttle knob (item 3 in Fig.3) to select the alarm parameter to be set; press the shuttle knob (item 3 in Fig.3), so that selected alarm parameter is displayed in reverse color. Rotate shuttle knob (item 3 in Fig.3) to achieve required value of the parameter: clockwise to increase the parameter value and counterclockwise to decrease the parameter value. Press the shuttle knob (item 3 in Fig.3) to confirm setting of this parameter. To adjust the next parameter, repeat steps described earlier. Rotate the shuttle knob (item 3 in Fig.3) to “OK”. Confirm settings and exit. The machine will run according to adjusted alarm parameters. Fig.16 Alarm setting Hint: 1) When adjusting alarm parameters, if upper or lower limit is exceeded, adjustment will be limited automatically. 2) Audio alarm can be closed, visual alarm can not be closed. 25 9.6 System setting Press the key “ ” (item 2 in Fig.3) three times, system setting interface will be displayed, as shown in Fig.17. Rotate the shuttle knob (item 3 in Fig.3) to select the system parameter to be set, press the shuttle knob (item 3 in Fig.3) so that selected system parameter is displayed in reverse color. Rotate “Shuttle adjustment/confirm” knob (item 3 in Fig.3) to achieve required value of the parameter: clockwise to increase the parameter value and counterclockwise to decrease the parameter value. Press the shuttle knob (item 3 in Fig.3) to confirm setting of this parameter. To adjust the next parameter, repeat steps described earlier. Rotate the shuttle knob (item 3 in Fig.3) to “OK”. Confirm settings and exit. The machine will run according to adjusted alarm parameters. Fig.17 System setting Hint: 1) When adjusting alarm parameters, if upper or lower limit is exceeded, adjustment will be limited automatically. 2) When adjusting time, year and month and day and time are set respectively. 3) Runtime and SN and version can not be adjusted. 4) Pressure unit switch, its corresponding setting and monitoring value switch with it. 26 9.7 Operation of humidifier In working interface, press shuttle key to select step position number in Fig.4. Rotate shuttle knob (item 3 in Fig.3) to achieve required value of the parameter: clockwise to increase the parameter value and counterclockwise to decrease the parameter value. Press shuttle key (item3 in Fig.3) to confirm setting of this parameter. Hint: 1) To modify machine parameters, carry out operations 9.3, 9.4, 9.5 and 9.6. After setting, disconnect power supply; the system will automatically save setting parameters. Next time the machine is turned on. It will run according to parameters set last time. 2) Parameters can only be modified by first pressing keys “ ” and “ ” (item 1 and 2 in Fig.3) at the same time and then connect power supply. 9.8 Start-up/standby Press the “ ” key, gas supply is active; Press it again, gas supply is stopped. 9.9 Audio paused of alarm When alarm occurs, if press the shuttle knob for 2s, alarm sound will be paused, but visual signal still exist and the symbol “ ” will be displayed on the screen until the alarm condition disappears. 27 9.10 Ventilation operation Connect power supply; Connect the breathing tube and mask; Select ventilation mode; Set parameters; Set alarm parameters; Start Ventilation. ! △ Warning: 1) Read this manual carefully before operation, use the machine strictly according to the instruction. During use of this machine, suitable inspiration parameters and alarm parameters shall be set according to patient conditions. During use of this machine, arrange breathing tubeline and cables with care to avoid twinning and patient suffocation. During use of this machine, never move or cover this machine at will; maintenance during use is not permitted. Alarm during use shall be timely handled. First ensure patient safety, and then carry out troubleshooting or necessary repair. Dripping or splash of liquid into this machine may cause damage or electric shock. 2) 3) 4) 5) 6) 9.11 On completion Press the “ ” key, turn off the system; Disconnect the breathing tube and mask; Pull out the power adapter from the main machine and AC power supply socket in the wall. △ ! Warning: Before disconnecting the wetting unit from main part of this machine, take out the water box to prevent back-filling of liquid into the machine, damaging the machine. 28 10 Alarm, warning and hint information △ ! Warning: If there is alarm during operation, safeguard the patient firstly, then check immediately to fix the fault. Please refer to below table of the alarm and warning information. Alarm and warning information Alarm and warning information MV low!! Cause MV is less than the set low limit Pup !! Ppeak exceeds the set upper limit Fup!! Frequency exceeds the set upper limit Flow!! Frequency is less than the set low limit Apnea!! No spontaneous breathing lasting for 8s to 12s. Discon!! Disconnect the breathing tube for 16s. Vt low !! Vt is less than the set low limit A alarm display when alarm audio is closed 29 11 Cleaning and maintenance 11.1 Clearance and disinfection of the contact part with patient Clearance and disinfection before first use Use cloth dipped in water or mild detergent to clean front panel and casing exterior as required. Use alkaline disinfection method to disinfect breathing tube (threaded pipe). Disinfection temperature shall not exceed 75℃ or 170℉. Refer to the operation manual of mask for mask’s Clearance and disinfection. Clearance and disinfection of reusable part The reusable parts of this machine include breathing tube and mask. Process for clearance and disinfection after operation: Use alkaline disinfection method to disinfect breathing tubes temperature shall not exceed 75℃ or 170℉. Refer to the operation manual of mask for mask. (threaded pipes). Disinfection Using times for the reusable part Under normal condition and no damage: Breathing tubeline can be used (after disinfection) for 50 times or for 6 months. Refer to the operation manual of mask for mask. 11.2 Cleaning of S9600 Before cleaning or conventional maintenance, ensure S9600 in non-operating status and disconnect S9600 from its power supply. Before cleaning, take down breathing tube, face mask, and wetting cup. Use warm water and mild detergent solution to lightly clean the piping that can be used repeatedly. Thoroughly wash the piping and dry it in the air. Use cloth dipped in water or mild detergent to clean front panel and casing exterior as required. Before insertion of power supply cable, thoroughly dry S9600. Precautions for cleaning: Do not use alcohol, acetone, chloride, or abrasive cleaning agent for cleaning. Do not use solution of temperature higher than 50°C (122°F) for cleaning. 30 11.3 Cleaning of wetting cup In case your device is not configured with wetting unit, it is not necessary to read the following prompts: Cut off power supply to the Non-invasive Ventilator. Remove ventilation pipeline, open side cover of the wetting unit, and remove wetting cup. Use detergent or washing solution (of temperature not exceeding 65°C/150°F) to clean the wetting cup. 11.4 Cleaning of filtering sponge The filtering sponge is placed in the filtering box at a side of the device and can be taken out directly. Use neutral cleaning agent for cleaning. After cleaning, place it in a cool place away from sunshine for drying. Do not knead the sponge during cleaning. The filtering sponge shall be replaced after one month of use. Before use of this machine, it is necessary to install dried filtering sponge. ! Note: △ 1) Do not install wet filtering sponge in this Non-invasive Ventilator; otherwise this machine may be damaged. 2) Failure to replace filtering sponge in time may affect your health. 3) In case of relatively serious external dusting or smoke, filtering sponge replacement interval shall be shortened according to particular conditions. 31 12 Maintenance ! △ Warning: 1. Do not use machine with any problem. 2. The machine can only be repaired by authorized personnel. If the user needs to repair,,This machine can only be operated by special qualified personnel after training. When necessary, our company can provide the necessary information 3. Only authorized and qualified personnel can do calibration of the machine, or special qualified personnel after training. ! △ Note: After maintenance, check the machine according to the Chapter of “Check before operation”. 12.1 Before everyday operation Before first operation, clean the surface of the machine everyday. 12.2 After operation of every patient Do disinfection after operation of every patient. 12.3 Assemble after disinfection Check the machine according to the chapter of “Check before operation” after disinfection. If any part is broken, replace or repair it immediately. 12.4 Every day or in case of needed Check the machine according to the chapter of “Check before operation”. If any part is broken, replace or repair it immediately. 12.5 Every month or over 300 hours Check the machine according to the chapter of “Check before operation”. If any part is broken, replace or repair it immediately. 32 12.6 Every year or operation over 4000 hours Maintain and check the machine completely; Replace the gasket; Check and calibrate: — Monitoring the value of flow; — Monitoring the value of pressure; 33 13 Disposal of wastes 13.1 Disposal of electronic and plastic parts ! △ Warning Do not dispose of electronic and plastic parts replaced from maintenance at option, to avoid environmental pollution. Dispose of electronic and plastic parts replaced from maintenance at option will cause environmental pollution. Local environmental protection laws shall be executed. 13.2 Scrap disposal of medical equipment When service life is over, do not dispose it as household waste, and dispose it separately. Please abide the local environment law for waste disposal. Please refer to Environmental Protection Agency or government or waste disposal company for waste disposal. 34 14 Alarm and handling If there is alarm during the operation, safeguard the patient firstly, then check immediately to fix the fault. Operator’s position: Visual alarm: operator at any position 1m from the display screen and within angle of 30° with horizontal plane of screen center. Audible alarm: operate at any position 1m from the machine. Before and after interruption of power supply, default alarm value will not change. Default alarm value can only be accessed for modification (including in storage) using a special tool. Volume of audible alarm: medium priority: 68dB Alarm priority: Priority Alarm way Continuous and repeated three tones and with 20 second interval Medium Alarm information: Alarm MV Low!! Pup!! Fup!! Priority Medium Medium Medium Setting range 0L~15L/min 20cmH2O~35cmH2O 1bpm~99bpm 35 Default value Alarming way 2.0 L/min When the monitoring value less than MV low limit of alarm, there will be audible alarm and visual alarm. 30 cmH2O When the monitoring value over the upper limit of Ppeak, there will be audible alarm and visual alarm. 40 bpm When the monitoring value over the upper limit, there will be audible alarm and visual alarm. Alarm F Low!! Apnea!! Discon!! Vt low!! Priority Medium Medium Medium Medium Setting range 1bpm~60bpm ON/OFF ON/OFF ON/OFF Default value Alarming way 1 bpm When the monitoring value less than the low limit, there will be audible alarm and visual alarm. OFF No spontaneous breathing lasting for 8s ~ 12s, there should be audible alarm and visual alarm. OFF Disconnect breathing tube lasting for 16s, there should be audible alarm and visual alarm. OFF When inspiratory pressure value over its upper limit, tidal volume do not reach its set value, there will be audible alarm and visual alarm. Cause of alarm and solution of alarm: Alarm Cause Solution of alarm Disconnect alarm In case serious air leakage is detected upon startup Check for correct connection of of this machine, corresponding type of alarm will pipeline with face mask; flash in the alarm box, with audible alarm. Press the audio paused key. Apnea alarm Under S/T and S mode, Upon startup of this Check patient ventilation status; machine, if breathing is not detected within set Check the connection of alarm time of 8s~12s, corresponding type of alarm breathing tube and mask; will flash in the alarm box, with audible alarm. Press the audio paused key. MV alarm Upon startup of this machine, if detected MV is Check patient ventilation status; higher than a set threshold, corresponding type of Check if the set threshold of MV alarm will flash in the alarm box, with audible alarm. is too low; Check the connection breathing tube and mask; 36 of Press the audio paused key. High Frequency alarm Upon startup of this machine, if detected breath Check patient ventilation status; frequency is higher than a set threshold, Check if the set threshold of Fup corresponding type of alarm will flash in the alarm is too low; box, with audible alarm. Press the audio paused key. Low Frequency alarm Upon startup of this machine, if detected breath Check patient ventilation status; frequency is lower than a set threshold, Check if the set threshold of Flow corresponding type of alarm will flash in the alarm is too high; box, with audible alarm. Press the audio paused key. High Ppeap alarm Upon startup of this machine, if detected patient Check patient ventilation status; airway pressure is higher than a set threshold, Check if Pup alarm threshold is corresponding type of alarm will flash in the alarm too low; box, with audible alarm. Press the audio paused key. Low Vt alarm Check patient ventilation status; Upon startup of this machine and inspiratory pressure is more than maximum inspiratory Check if maximum inspiratory pressure, if detected Vt is lower than its set pressure value and Vt set value value, corresponding type of alarm will flash in the are suitable; alarm box, with audible alarm. Press the audio paused key. 37 15 Troubleshooting Fault Cause analysis Method of correction The machine can only generate low pressure Blocking of filtering sponge or air outlet; or pressure delay is set in CPAP mode. Clean or replace filtering sponge, clean air outlet, if necessary, cancel the delay or set the delay again Too high noise Ventilation pipeline not or incorrectly connected; air leakage in face mask or breathing tubeline; connection between wetting cup and the breathing machine not properly sealed Check for correct pipeline connection; After startup, the system prompts fault in fan. Fault in the fan or connection problem Connect with sales service center of our company. After startup, the machine does not run. Power supply plug not properly connected; Check for correct connection of the breathing machine with its power supply (first turn off the AC power supply); check availability of indoor power, e.g. by light; Damage inside power supply Check for correct breathing tubeline; Check for normal connection between the wetting cup and the main part of the breathing machine. Connect with sales service center of our company. The fan runs normally, but the pressure obviously does not conform to set pressure Output air from the machine is relatively hot. Air flow output by the machine is too small. Water present in the face mask Incorrect connection of breathing tubeline; Air leakage in face mask or breathing tubeline. Too dirty filtering sponge; Blocked air inlet; Poor air circulation due to the machine too near wall, curtain, or other object. Blocking of air inlet; The machine is in delayed pressure rise. Condensate in face mask due to low room temperature. 38 Check if connection is correct and stable; Connect with sales service center of our company. Clean or replace filtering sponge; Check air inlet; 20cm Move machine to a place with free air circulation, at least 20cm from wall, curtain, or other object Check gas inlet; Shorten ramp time. Lower temperature of humidifier or increase ambient temperature. 16 Main technical specification 16.1 Environment conditions Working environment: Ambient temperature 5 ℃~ 35 ℃ Relative humidity 15 %~ 95 % Atmospheric pressure 830 hPa~1060 hPa Storage environment: Ambient temperature -20 ℃~+60 ℃ Relative humidity 15 %~ 95 % Atmospheric pressure 500 hPa~1060 hPa 16.2 Classification Classified according to IEC60601-1,S9600 belong to: ClassⅡequipment; Type BF equipment; IPX1; Common equipment; Continuous operation; This machine can be disinfected. 16.3 Power supply Power supply: DC 24 V(-15 % ~ +25 %), 2.5 A; Power adapter: AC input 100 V -240 V~, Frequency 50HZ /60 HZ DC output 24 V,2.5 A 16.4 Electromagnetic Compatibility ! △ Warning: 1) Cell phone and other radiation equipment used near the machine will cause unexpected problem to Non-invasive Ventilators. If there is radio frequency radiation source nearby, working status of the equipment should be monitored. 2) The other equipment added to or near Non-invasive Ventilators will lead to disturbance to the machine. Before used to the patient, check if the machine works normally under the set values. 39 16.5 Ventilation mode ——CPAP ——Spontaneous Breath (S) ——Time control (T) ——S/T ——PC 16.6 Ventilation parameter adjustment AVPAS ——Adjusting range: ON/OFF ——Step: 1 Tidal volume ——Adjusting range:200mL~1500mL ——Step: 10 mL ——Allowable error:>100 mL,± 20 %; ≤100 mL,± 20 mL Frequency ——Adjusting range:3 bpm~ 40 bpm ——Step:1 bpm ——Allowable error:±15 % Inspiratory time ——Adjusting range:0.0 s ~ 3.0 s ——Step: 0.1 s ——Allowable error:±15 % or ± 0.3 s, whichever is the greater Pressure limit ——Adjusting range:20cmH2O ~ 35 cmH2O ——Step: 0.5cmH2O IPAP ——Adjusting range:4 cmH2O ~ 30 cmH2O ——Step: 0.5cmH2O ——Allowable error:±(2 % of full scale+8% of actual reading) IPAPMAX ——Adjusting range:4 cmH2O ~ 30 cmH2O 40 ——Step: 0.5 cmH2O ——Allowable error:±(2 % of full scale+8 % of actual reading) IPAPMIN ——Adjusting range:4 cmH2O ~ 30 cmH2O ——Step: 0.5cmH2O ——Allowable error:±(2 % of full scale+8 % of actual reading) EPAP ——Adjusting range:4 cmH2O ~ 25 cmH2O ——Step: 0.5cmH2O ——Allowable error:±(2 % of full scale+8 % of actual reading) CPAP ——Adjusting range:4 cmH2O ~ 20 cmH2O ——Step: 0.5cmH2O ——Allowable error:±(2 % of full scale+8 % of actual reading) Ramp time ——Adjusting range:0 min ~ 60 min ——Step: 1 min ——Allowable error:± 15 % Rise time ——Adjusting range: Auto adjusting,0.1 s~ 0.6 s ——Step: 0.1 s ——Allowable error:± 30% Inspiratory trigger ——Adjusting range: Auto adjusting,1~3 ——Step: 1 Expiratory trigger ——Adjusting range: Auto adjusting,1~3 ——Increment:1 Flex ——Adjusting range:Off,1~3 ——Step: 1 Humidifier ——Adjusting range:0~5 41 ——Step: 1 Automatic function ——Adjusting range: OFF、ON ——Step: 1 16.7 Ventilation parameter Monitoring range The following are monitoring parameters under the environment of body temperature and pressure-saturated. Fig display: Monitoring parameter Range Resolution Frequency 0 bpm ~ 100 bpm 1 bpm VT 0 L~2000mL 1 mL Accuracy ±15 % >100 mL,± 20 %; ≤100 mL,± 20 mL. >3.0 L/min,± 20 %; ≥10L/min,0.1L/min MV 0 L/min~99 L/min Tinsp 0.0 s ~ 3.0 s <10L/min,0.01L/min 0.1s ≤3.0L/min,±0.6L/min. ± 15 % or 0.3s, whichever is greater IPAP EPAP 0 cmH2O ~40 cmH2O 0.1cmH2O ±(2% of full scale+8% CPAP Waveform display: —— airway pressure(under all modes) Hint: The machine cannot record all the adjusting and monitoring values. 42 actual reading) The purpose, sensor position, type and sampling method of control, measurement and display device: Purpose Sensor position Type Sampling method Airway pressure inhaling end pressure- voltage, simulated data Choose average value IPAP inhaling end pressure- voltage, simulated data Choose average value EPAP inhaling end pressure- voltage, simulated data Choose average value CPAP inhaling end pressure- voltage, simulated data Choose average value Frequency internal time and digit data Inspiratory time internal time and digit data VT inhaling end Flow inhaling end 43 from multiple sampling from multiple sampling from multiple sampling from multiple sampling Choose average value from multiple sampling Choose average value from multiple sampling flow-voltage, Choose average value simulated data from multiple sampling flow- voltage, Choose average value simulated data from multiple sampling 16.8 Alarm, hint and protection Apnea alarm Apnea time lasts for 8 s ~ 12s and no spontaneous breath, then there will be audible alarm and visual alarm. Disconnect alarm Disconnect the breathing tube for 16s,then there will be audible alarm and visual alarm. Alarm audio paused When an alarm occurs, the alarm sound may be paused by pressing the audio paused key for 2s, but the alarm indication will still display on the screen, unless the alarm condition disappear. Audio paused time: ≤120 s. Maximum pressure limit Under normal conditions, Maximum pressure limit is less than 35cmH2O. Under Single fault condition, Maximum pressure limit is less than 40 cmH2O. All alarm audio will be closed by closing alarm audio function, the display“ ”shows that alarm audio is closed. 16.9 Noise During normal operation, noise heard by patient at 1m from this machine is ≤45dB(A). 44 17 Move, storage and transportation 17.1 Move ! △ Note: Keep the balance and stable of the machine when move the machine. Angle of machine inclination should be less than 10°when moving. Before moving, all the power cable and breathing circuit pipes should be pull out from the machine. Don’t be toppled and collided when move the machine. 17.2 Storage Non-invasive Ventilators shall be stored indoors with ambient temperature of - 20℃ ~ 60℃, relative humidity of 15% ~ 95 % and atmospheric pressure at 500 hPa ~ 1060 hPa, free of corrosive gases and not affected by strong magnetic field, and with good ventilation. 17.3 Transportation The machine to be transported shall be packed well. Each set of machine shall be secured in its package and soft material of adequate thickness shall be inserted in between the package and machine to protect against movement and rubbing against each other during transportation. The package shall be protected from damp and rain to ensure that the machine will not be damaged in natural condition. The packed machine can be transported by general means. The product shall be protected from rain, damp, corrosion and against strong vibration. Turn over at handling is forbidden. Transportation environment Ambient temperature -20 ℃~60 ℃ Relative humidity 15%~ 95% Atmospheric pressure 500 hPa~1060 hPa 45 18 After-sales service commitments For all Non-invasive Ventilators manufactured by this company, provided that user has adhered to specification on storage, transport, and operation, our company will provide one year of warranty (starting from the day of sales) against product quality defect resulting in failure of normal operation, according to state stipulations. For products beyond this warranty period (including those not in the scope of warranty), our company will still be responsible to provide maintenance service, only charging costs of such maintenance. The following situations are not in the scope of warranty: ——Damage or deform due to collision or falling; —— Damage due to ingress of water or foreign matter into this machine ——Abnormal operation due to dismantling of this machine by user without approval ——Damage due to force majeure (e.g. natural disaster) In case of fault or doubt during use, please contact the sales agent or the manufacturer. 46 2.782.062AS-A 2020.11.26 Thank you for choosing S9600 Non-invasive Ventilator. Please read this manual before operation, and keep it for reviewing. Manufacturer: Nanjing Superstar Medical Equipment Co., Ltd. Address: The 2nd and 3rd Floors, No. 6 Building, No. 9 Bofu Road, Jiangbei New Area, 211505 Nanjing, PEOPLE’S REPUBLIC OF CHINA Post Code: 211505 Tel: 0086-25-68108300 / 0086-4001013812(service) EXP20210521-0293